Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

NCT ID: NCT06274190

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2025-08-17

Brief Summary

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.

Detailed Description

Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).

Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.

Conditions

Rectal Cancer; LARS - Low Anterior Resection Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pre-Delphi patient focus group

During this focus group, we aim to achieve various goals:

• To gain insight into the bowel symptoms and the consequences patients experienced after treating rectal cancer
• To understand the expectations of the patients regarding an electronic bowel diary
• To determine whether the questions/items derived from the literature study for the bowel diary are clear and understandable for the patients
• To explore other relevant questions/items that should be added to the bowel diary

We will include 8-12 patients in this focus group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Delphi survey

In this Delphi survey, a multidisciplinary group of experts and patients will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey.

We will recruit 10-18 Delphi panelists per area of expertise. These panelists are experts with international expert recognition in treating bowel symptoms in the following health care categories (abdominal surgeons, digestive/radiation oncologists, specialized pelvic floor muscle physiotherapists, nursing specialists). In addition, we will include one group comprising 10-18 patients in the Delphi survey, ensuring a comprehensive and holistic perspective on treating bowel symptoms across various healthcare categories.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-Delphi patient focus group

During this focus group, our objective is to ensure that both the questions and answers are meaningful.

We will include 8-12 patients in this focus group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usability of e-diary

The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.

To evaluate the usability of the e-diary, a group of 10 patients will participate in the assessment using the System Usability Scale (SUS).

Furthermore we will have conversations with these patients regarding the use of the application: complexity, need for additional support, coherence of the application, user-friendliness, and the need for prior knowledge.

Group Type: EXPERIMENTAL

bowel e-diary

Intervention Type: DIAGNOSTIC_TEST

This bowel diary will be available on the smartphone in the form of an application.

Psychometric properties of e-diary

To evaluate the validity of the e-diary, encompassing test-retest reliability, construct validity and responsiveness, participants will be instructed to use the e-diary for two separate 7-day periods.

Group Type: EXPERIMENTAL

bowel e-diary

Intervention Type: DIAGNOSTIC_TEST

This bowel diary will be available on the smartphone in the form of an application.

Interventions

bowel e-diary

This bowel diary will be available on the smartphone in the form of an application.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the Informed Consent Form (ICF).
• Proficient in reading, comprehending, and conversing in Dutch .
• Patients diagnosed with a rectal tumour based on a pathology report.

Exclusion Criteria

• The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
• Experienced fecal incontinence prior to undergoing surgery.
• Are affected by neurological disorders affecting bowel function.
• Already underwent previous pelvic surgery, previous pelvic radiation or rectal surgery for non-cancer reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Responsible Party

Inge Geraerts

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inge Geraerts, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S68746

Identifier Type: -

Identifier Source: org_study_id